NCT00593294

Brief Summary

Oral contraceptive therapy is routinely used for the treatment of menstrual disturbances of patients with polycystic ovary syndrome (PCOS). To date, the cardiovascular risk (CVR) of the oral contraceptives (OC) are known but no data are available on the CVR in PCOS patients treated with OC or physical exercise. The purpose of this study is to compare the effects of OC to physical exercise on the CVR of PCOS women and show the hormonal and metabolic effects of these two different treatment. We hypothesize that physical exercise has the same beneficial effects of OC therapy on hormonal and metabolic features of PCOS women with less cardiovascular consequences.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
Last Updated

January 15, 2008

Status Verified

December 1, 2007

Enrollment Period

1.7 years

First QC Date

January 4, 2008

Last Update Submit

January 14, 2008

Conditions

Polycystic Ovary Syndrome

Keywords

PCOSoral contraceptivesphysical exerciseCVR

Outcome Measures

Primary Outcomes (1)

  • Primary Outcomes: Intima media thickness by carotid ultrasonography (US) and Flow Mediated Dilation by brachial artery US

    Basal and after 3 and 6 months

Secondary Outcomes (1)

  • Secondary Outcomes: Clinical, hormonal, and metabolic assessments

    Basal and after 3 and 6 months

Study Arms (3)

A,1,I

EXPERIMENTAL
Behavioral: Physical exercise

B, 2, II

ACTIVE COMPARATOR
Drug: OC - Drospirenone plus Ethynylestradiol

C,3,III

PLACEBO COMPARATOR
Dietary Supplement: Vitamin, polyvitamins tablets

Interventions

Physical exerciseBEHAVIORAL

45 minutes each day for three times/week for 6 months

A,1,I
OC - Drospirenone plus EthynylestradiolDRUG

1 cp for 21 days each month for 6 months of OC (Drospirenone 3 mg plus Ethynylestradiol 30 microgram = Yasmin, Schering, Milan, Italy)

B, 2, II
Vitamin, polyvitamins tabletsDIETARY_SUPPLEMENT

Tablet of vitamin 1cp for 21 days each month for 6 months

C,3,III

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Polycystic ovary syndrome

You may not qualify if:

  • Age \<18 or \>40 years
  • BMI higher than 30 and lower than 18
  • Pregnancy
  • Hypothyroidism, hyperprolactinemia, Cushing's syndrome, nonclassical congenital adrenal hyperplasia, use of OC, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic or antiobesity drugs or other hormonal drugs within the previous 6 months
  • Subjects with neoplastic, metabolic (including glucose intolerance), hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, or malabsorptive disorders, cephalea)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II"

Naples, Naples, 80131, Italy

Location

Related Publications (1)

  • Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.

    PMID: 14711538BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary SyndromeMotor Activity

Interventions

ExerciseEthinyl EstradiolVitamins

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsMicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Francesco Orio, MD,PhD

    Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy

    PRINCIPAL INVESTIGATOR

  • Gaetano Lombardi, MD

    Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy

    STUDY DIRECTOR

  • Stefano Palomba, MD

    Chair of Obstetrics and Gynecology, University "Magna Graecia" Catanzaro, Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 15, 2008

Study Start

January 1, 2006

Primary Completion

September 1, 2007

Study Completion

December 1, 2007

Last Updated

January 15, 2008

Record last verified: 2007-12

Locations

IT(1)